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Trial record 63 of 146 for:    Hydrocodone

A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery

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ClinicalTrials.gov Identifier: NCT02197156
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.

Brief Summary:
The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: 10 mg HC-ER Drug: 20 mg HC-ER Drug: 30 mg HC-ER Drug: 40 mg HC-ER Drug: 10 mg HC / 325 mg APAP Drug: Matching Placebo Phase 2

Detailed Description:
Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery
Study Start Date : August 2002
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Hydrocodone

Arm Intervention/treatment
Experimental: 10 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 10 mg
Drug: 10 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Hydrocodone bitartrate extended release (HC-ER)
  • Zohydro Extended Release (ER)

Experimental: 20 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 20 mg
Drug: 20 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Hydrocodone bitartrate extended release (HC-ER) 10 mg
  • Zohydro Extended Release (ER)

Experimental: 30 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 30 mg
Drug: 30 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Hydrocodone bitartrate extended release (HC-ER) 30 mg
  • Zohydro Extended Release (ER)

Experimental: 40 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 40 mg
Drug: 40 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Hydrocodone bitartrate extended release (HC-ER) 40 mg
  • Zohydro Extended Release (ER)

Active Comparator: 10 mg HC / 325 mg APAP
10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)
Drug: 10 mg HC / 325 mg APAP
Single dose
Other Name: 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)

Placebo Comparator: Placebo
Matching placebo
Drug: Matching Placebo
Single dose
Other Name: Placebo




Primary Outcome Measures :
  1. The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI) [ Time Frame: 0-12 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject was able to read and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document and given the opportunity to ask questions regarding the study prior to the performance of any study- specific procedures.
  • Subject required primary unilateral first metatarsal bunionectomy surgery with or without hammertoe repair with no other collateral procedures allowed
  • Subject was male or female at least 18 years of age.
  • Subject weighed > or = 100 lbs (pounds).
  • Subject was willing and able to comply with the protocol and able to score their pain intensity.
  • Subject was in good health as determined by the investigator on the basis of medical history, physical examination, Electrocardiogram (ECG) and screening laboratory results.
  • Subject had not developed a condition or complications as result of the bunionectomy procedure that would preclude their participation in the study.
  • Subject was willing and able to remain at the recovery day care center for the entire 24-hour Treatment period.

Exclusion Criteria:

  • Subject was pregnant or lactating.
  • Subject had been on an investigational drug within 30 days prior to the initiation of study drug.
  • Subject had donated blood or blood components within one month prior to study (Check-in).
  • Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or ketorolac.
  • Subject had a known history of substance or alcohol abuse within 2 years prior to Screening.
  • Subject tested positive to drug screens (cocaine, marijuana, opioids, benzodiazepines, and barbiturates) that could not be justified by prescription use.
  • Subject had a condition that would contraindicate the use of opioid analgesia (e.g., pulmonary disease or paralytic ileus).
  • Subject had received a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI) carbamazepine, quinidine, and/or tricyclic antidepressants (TCA) compounds within 1-month prior to Check-in.
  • Subject had received opioids, tranquilizers, sedatives, or hypnotics within 48 hours prior to Check-in.
  • Subject had received corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics within 24 hours prior to Check-in.

Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT02197156     History of Changes
Other Study ID Numbers: ELN154088-201
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hydrocodone
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents